Sunday, 19 August, 2018

Heart Meds Recalled After Discovery of Possible Carcinogenic Impurity

Ministry of Health recalls medicines containing chemical suspected to cause cancer - Oman Ministry recalls seven medicines over cancer fears
Ben Pena | 20 July, 2018, 21:44

The development comes following indications of the presence of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active pharmaceutical substance supplied by Chinese company Zhejiang Huahai Pharmaceuticals and used in these prescription medications.

The companies listed below are recalling all lots of non-expired products that contain the ingredient valsartan supplied by a third-party.

A common blood pressure and heart drug manufactured in bulk by a Chinese company and sold worldwide may have contained an impurity linked to cancer since 2012, European regulators said on Tuesday. If you can't find the information on the bottle, you should contact your pharmacy.

The recalled medications include Valsartan Tablets manufactured by Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals, as well as Valsartan/Hydrochlorothiazide Tablets from Solco Healthcare and Teva Pharmaceuticals.

The US Food and Drug Administration (FDA) has now taken the same step, after Zhejiang Hauhai had alerted authorities that it had discovered impurities in the ingredient that it produces. The recent detection of higher levels of NDMA in raw materials imported from a particular supplier in China (Zheijhiang Huahai Pharmaceuticals Linhai China) indicates improper processes and poor monitoring at the suppliers facility.

Mays party denies cheating in Brexit parliament vote
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A similar recall notification issued by the Provincial Pharmacovigilance Centre of Punjab on July 16, 2018, named a number of local pharmaceutical companies who are allegedly importing the contaminated raw material from China. Environmental Protection Agency, humans exposed to NDMA for an extended period of time may develop liver damage, which can lead to cancer.

"The recall is huge, based on the volume and the large number of patients it could have impacted", said Brito, "but we believe this could get offset by other players stocking up in short term".

The FDA said it would continue to investigate the matter and also assess the effects on patients while establishing measures to reduce the impure component in future batches.

The agency also said that patients taking valsartan, or medicines that use it as an ingredient, should continue taking it until they have a substitute. Instructions for returning recalled products and crediting are given in the recall letter. It noted that Valsartan products on the Barbados market are produced by Novartis and Jubilant and are not subject to the recall.

"[I'm] very angry. I'm hurt".

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